Profence Nitrile Biodegradable 300 (Tzmo Romania SRL)
by Hartalega NGC Sdn. Bhd. 5 variants
Ref P-BIOD-NBPF-300- VBLU -MModel Biodegradable Nitrile Powder Free Examination Gloves
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955100777HNGCTFMD004XC 19551017624911 | Date21 Feb 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Biodegradable Nitrile Examination Gloves
- Model / Reference
- Biodegradable Nitrile Powder Free Examination Gloves, P-BIOD-NBPF-300- VBLU -M
- Primary DI / UDI-DI
- 19551017624911
- Basic UDI-DI
- 955100777HNGCTFMD004XC
- Unit of Use DI
- 09551017624914
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- MY-MF-000010459
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Hartalega Ngc Sdn. Bhd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No